Intranasal corticosteroids show varying efficacy for chronic rhinosinusitis with nasal polyps
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Key takeaways:
- Sinusitis-related quality of life might improve with intranasal corticosteroid rinse and exhalation delivery systems compared with placebo.
- Stent/dressing and spray administration of intranasal corticosteroids probably will improve nasal obstruction symptoms compared with placebo.
- The examined interventions had no important differences in adverse events.
The effectiveness of different modalities for delivering intranasal topical corticosteroids in treating chronic rhinosinusitis with nasal polyps varied, according to a review published in The Journal of Allergy and Clinical Immunology.
Based on this review, stent, spray and exhalation delivery systems (EDS) appear beneficial across the widest range of outcomes important to patients, Derek K. Chu, MD, PhD, assistant professor in the department of medicine at McMaster University, Hamilton, Ontario, Canada, and colleagues wrote.
“Chronic rhinosinusitis with nasal polyposis is an inflammatory disease of the nasal mucosa and paranasal sinuses lasting for a minimum of 12 weeks. It affects about 2% to 4% of people in the U.S. and Europe with symptoms such as nasal obstruction, smell impairment, nasal drainage and facial pain and pressure,” Chu told Healio.
To treat CRSwNP, intranasal topical corticosteroids (INCS) are directly applied to the nasal and sinus mucosa using sprays, rinses, drops, EDS, stents and dressings, nebulization, local injections and high-dose sprays.
“However, it remains uncertain which administration route should be prioritized — eg, spray or rinse — as well as on how and when they should be used with respect to other therapies and which outcomes benefit from their use,” Chu said.
The authors prepared this systematic review and network meta-analysis to inform a clinical practice guideline update from the American College of Allergy, Asthma & Immunology and American Academy of Allergy, Asthma & Immunology’s Joint Task Force for Allergy-Immunology Practice Parameters (JTFAIPP).
The review’s design, results
The authors examined 61 unique randomized control (RCTs) trials published through September 2021 comprising 7,176 participants investigating eight modalities for using INCS to treat CRSwNP.
The trials had a median number of 70 participants (range, 18-748; mean age, 46.1 years; range of means, 31-54; mean percentage of women, 40%). Interventions had a median duration of 12 weeks (range, 2-260).
Also, 91.3% of the trials included patients who only had CRSwNP, and the remainder included populations with mixed patients. Plus, 31.9% had asthma, although only 40.1% reported data about it.
Fourteen RCTs (n = 950) compared the effect of spray, rinse, stent/dressing, high-dose spray, EDS and placebo on disease-specific quality of life (QoL), finding with low-certainty evidence that only rinse (mean difference [MD], –6.83; 95% CI, –11.94 to –1.71) and EDS (MD, –7.86; 95% CI, –14.64 to –1.08) might lead to improvements. The other interventions had no clear effect.
Next, 31 RCTs (n = 4,539) compared those same delivery routes plus drops on nasal obstruction symptoms. Spray (MD, –0.51; 95% CI, –0.61 to –0.41; high certainty), stent/dressing (MD, –0.31; 95% CI, –0.54 to –0.08; moderate certainty) and EDS (MD, –0.35; 95% CI, –0.51 to –0.18; moderate certainty) improved symptoms. Also, high-dose spray (MD, –0.51; 95% CI, –0.85 to –0.16; very low certainty) might produce improvements. Rinse and drops did not have any clear difference.
Eight trials (n = 1,306) found that EDS (risk difference [RD], –4.3%; 95% CI, –6.9% to –0.9%; moderate certainty), stent/dressing (RD, –10.3%; 95% CI, –12.9 to –0.2%; low certainty) and spray (RD, –10.7%; 95% CI, –13 to –2.1%; very low certainty) reduced rates of necessary rescue surgeries compared with placebo, although drops had no clear benefit and no particular treatment was superior to any other in head-to-head comparisons.
In 25 studies (n = 4,036), stent INCS improved smell with moderate certainty (MD, 3.81; 95% CI, 1.22-6.39). With low certainty, the researchers also found that spray (MD, 3.24; 95% CI, 2.05-4.42), EDS (MD, 4.1; 95% CI, 1.69-6.52) and drops (MD, 5.03; 95% CI, 1.89-8.18) might improve smell, but rinse did not clearly affect smell.
Nasal polyp scores were measured in 24 trials (n = 3,668). Spray (MD, –0.64; 95% CI, –0.85 to –0.43; high certainty) and EDS (MD, –0.56; 95% CI, –0.97 to –0.14; moderate certainty) reduced the size of nasal polyps, but other interventions did not have any clear effect compared with placebo, with very low to low certainty evidence.
Five RCTs (n = 397) found that stent/dressing, spray, rinse, drops and nebulizer had no clear effect on imaging scores, based on the Lund Mackay scale, with very low to low certainty evidence.
Finally, 10 trials (n = 595) found that stent/dressing, spray, rinse, nebulizers, and high-dose spray had no clear effect in improving endoscopy scores measured on the Lund-Kennedy scale compared with placebo, with very low certainty.
An analysis of adverse events showed no important differences between any of the INCS delivery routes and placebo, with moderate certainty for INCS spray and very low to low certainty for the other delivery routes.
Conclusions, next steps
“The comparative efficacy and safety of the different INCS approaches were different across different outcomes,” Chu said.
“Multiple delivery forms of INCS are viable therapeutic options for CRSwNP, resulting in improvement of patient-important outcomes. INCS via stent, spray and EDS appear to be beneficial across the widest range of considered outcomes,” he continued.
Overall, EDS administration was most beneficial in five of the nine outcomes analyzed by the authors, with spray most beneficial in four of the outcomes and stent the most beneficial in three.
The researchers further concluded that each method of administration sufficiently delivers corticosteroids to the targeted mucosa with benefits that are important to patients, although they noted that further research should address additional interventions. Also, future RCTs should more robustly address patient-important outcomes and reduce imprecision with larger and more diverse sample sizes in multicenter studies, Chu said.
In the meanwhile, the authors expect the JTFAIPP to publish the associated guideline soon. Along with the task force’s previous research, the authors said, it will inform doctors how to achieve optimal outcomes for patients with CRSwNP.
“Doctors can use this study and its associated guideline to inform shared decision-making with patients with CRSwNP regarding whether to use INCS or not and, if so, which approach might be most consistent with their individual values and preferences,” Chu said.
Reference:
For more information:
Derek K. Chu, MD, PhD, can be reached at chudk@mcmaster.ca.
Perspective
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The results are not too surprising, although I would have expected an improvement in QoL if nasal symptoms scores and polyp size were improved. Perhaps it is the sense of smell that is driving the QoL problems.
I have had a similar experience. CRSwNP is notoriously difficult to treat medically and surgically, but INCS does offer some benefit and is low cost for patients. Although it perhaps is the most effective means of application, EDS often is not covered by insurance, and it is very costly.
I think the data support the use of these medications as first-line therapy for patients, although careful follow-up and consideration for more effective therapies such as biologics are important.
As the authors pointed out, there are varying degrees of heterogeneity with these studies. Entry criteria may vary, with some patients having had surgery prior to the intervention and some not. We need to know if there is additional benefit in using INCS after surgery compared with using INCS instead of surgery.
There is limited information on minimally important differences in most of the measures other than the QoL measure, the SNOT-22. I agree that research is needed to identify meaningful measures with meaningful minimally important differences and that large, randomized trials comparing treatment options with standardized inclusion criteria and outcome measures are needed.
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